Chemical Regulation under REACH

Overview:

Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) is the European Union’s (EU) chemical management regulation. It is an ambitious chemical control initiative with significant duties placed on industry. REACH is still relatively new -- effective as of June 2007 -- and its structure is still in flux. Companies whose businesses are implicated by REACH need skilled consultants and scientists who are not only familiar with the current regulatory framework, but who are also equipped to guide clients as that framework changes.

The Acta Group (Acta®) is uniquely well-suited to navigate the 140 different articles, 17 distinct annexes, almost 300 pages of text, and hundreds of pages of guidance that currently comprise REACH. Our professionals have been extensively involved in REACH and can assist clients in complying with REACH today and assist in foreseeing the future developments of REACH.

Our Experience:

Since REACH’s inception, Acta science and regulatory professionals have actively assessed the legislation and its implications and have prepared clients for its requirements. Our professionals include EU-based Regulatory Specialist Emma Louise Jackson, CBiol MSB, who delivers skilled REACH assistance, including classification and labeling of substances and mixtures, testing strategy advice, literature searching and reliability assessment, and compilation of regulatory documents, such as IUCLID 5 and Chemical Safety Reports (CSR). She is an excellent resource for preparation of Safety Data Sheets (SDS) and product labels, as well as liaising with various regulatory authorities. Amy Jackson supports clients in all facets of REACH compliance. She prepares and submits dossiers using IUCLID for lead and joint registrations, prepares CSR documentation, engages with supply chain interaction, develops exposure scenarios, and prepares classification, labeling, and packaging (CLP) notifications. Ms. Jackson is particularly knowledgeable in organic chemistry and physico-chemical properties testing. Also in the EU, Louise Boardall provides experienced support to Acta’s Regulatory Specialists in the technical areas of physical chemistry and analytical methods, efficacy, toxicology, and ecotoxicology. She is also proficient in dossier preparation, data assessment, statistics packages such as SPSS and STATA, and utilization of national authority websites and databases.

Leading Acta's science team is Jane Vergnes, Ph.D., DABT®. Dr. Vergnes, an esteemed toxicologist with an impressive track record of success directing global product stewardship for Fortune 500-listed chemical companies before joining Acta, has particular expertise in toxicological testing within the regulatory framework of REACH, including study design, laboratory practices, and data requirements for new chemical introductions, having started her career as a research scientist and laboratory supervisor. Brian Xu, M.D., Ph.D., DABT®, is a board-certified toxicologist with an M.D. in pathology and a Ph.D. in pharmacology and toxicology, who also works in this area. With over 15 years of industry experience as a senior toxicologist and scientist at major chemical companies, he assists clients in designing safety testing, risk assessment, product safety, and regulatory compliance programs under REACH. Oscar Hernandez, Ph.D., former Director of the Risk Assessment Division (RAD) in the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) offers expert scientific support and understanding of regulatory processes for chemicals being reviewed pursuant to REACH and other international chemical control regulations.

Acta's scientific team includes Lara Hall, M.S., a Registered Quality Assurance Professional for Good Laboratory Practice (RQAP-GLP). Ms. Hall offers clients expertise in the monitoring, quality assurance, and interpretation of ecotoxicology, environmental fate, physical-chemical properties, product chemistry, and analytical method validation studies in support of submissions under REACH. Lauren Graham, Ph.D., utilizes her background in science communication to assist industry groups engaged in legislative and regulatory advocacy, testing and compliance, and public outreach and communications. Prior to joining B&C® Consortia Management, L.L.C., Dr. Graham engaged with international leaders in the chemical sciences across industry and academia at the Royal Society of Chemistry, the United Kingdom’s professional body for chemical scientists. Molly R. Blessing is a chemist providing technical support in chemistry and analytical methods, and is experienced with dossier preparation and with identification and assessment of the analytical data needed to meet REACH requirements. Karen Lorusso is a Regulatory Consultant with a focus on the classification and labeling of substances and mixtures. She has experience with submitting dossiers in REACH-IT and preparing and submitting dossiers in IUCLID6.

What We Do:

Acta’s extensive involvement in REACH makes us especially suited to address client issues that arise under the regulatory scheme. Areas in which we advise clients include the following:

Provide regular updates on the latest REACH developments, including new guidance and tools

Consortia Management –

Identify potential consortium partners and forming consortia

Provide targeted technical services to consortia

Representative Services –

Only Representative (OR) services

Third Party Representative (TPR) services

Representative Engagements:

Acta routinely assists EU and non-EU clients in evaluating the pros and cons of all aspects of REACH.

Acta routinely provides tailored client REACH training.

Acta successfully worked with EU counsel to file the first and successful appeal of a decision in association with REACH.

Acta successfully worked with an industry association in obtaining clarity on procedural aspects of an EU process while engaging appropriate European Commission (EC) and Member State personnel to assist with complex administrative process, classification, and trade issues.

Acta successfully partnered with EU counsel to work cooperatively with the EC on behalf of an industry association that concluded in legal action being taken against the EC resulting in a successful final outcome.